Predicting Psychotic Relapse Using Speech-Based Early Detection

ConditionPsychosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorDouglas Mental Health University Institute

About this trial

Psychotic disorders, including schizophrenia and affective psychosis, are severe mental health conditions marked by recurrent episodes that contribute to long-term disability. Relapses, characterized by the re-emergence of psychotic symptoms after remission, are a critical factor in the progression of these disorders, increasing risks such as suicide, cognitive impairment, and unemployment. This study aims to develop a novel, speech-based digital model to predict relapses in individuals with psychosis. Building on previous research into language abnormalities in schizophrenia, the study will employ a longitudinal design across Early Psychosis Intervention (EPI) clinics in Ontario and Quebec to advance relapse prediction

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age must be 16 years and older

Diagnosis must meet DSM-5 criteria for psychotic disorders, including schizophrenia, schizoaffective disorder, or related conditions

Fluency in English or French

Must be currently receiving treatment through an EPI program

Disqualifiers

Severe comorbid speech or language disorders (e.g., aphasia)

Primary diagnosis of non-psychotic disorders

Inability to provide consent or complete assessments

Trial population

This study population will consist of approximately 250 patients experiencing or having experienced psychosis, enrolled in the EPI programs.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Early Psychosis Patients

Trial outcomes

Primary outcomes

1

Likelihood of relapse estimated using Speech-NLP Metrics

This primary outcome will assess the ability of speech-based NLP metrics (coherence, connectedness, and complexity) to predict impending relapses in psychosis. Monthly speech samples will be analyzed to determine if changes in these metrics can distinguish timepoints preceding relapses from those not followed by relapse, with the aim of predicting relapses up to four weeks in advance. The likelihood of relapse is a numerical probabilistic estimate without any units. Outcome definition: Occurrence of relapse (i.e., psychiatric hospitalization, an increase in the level of psychiatric care, or substantial clinical deterioration \>1wk that requires \>25% increase in Defined Daily Dose equivalents of antipsychotics)

Time frame
Monthly, up to 24 months
2

Generalization of Speech-Based Relapse Prediction Models Across Languages and Genders

This outcome will assess whether the speech-based relapse prediction models are valid and perform equally well across different languages (English and French) and genders (male and female). The study will evaluate how sociodemographic factors such as language and sex impact the predictive accuracy of the models. NLP metrics (coherence, connectedness, complexity) will be correlated with clinical outcomes, and model performance will be compared across linguistic and gender subgroups to ensure generalizability.

Time frame
Monthly, up to 24 months

Secondary outcomes

1

Likelihood of relapse estimated using multi-level speech features

This exploratory outcome will assess the likelihood of relapse prediction by integrating acoustic features (e.g., speech rate, intonation), prosodic features (e.g., rhythm, pitch), and sentiment analysis into the primary measures (coherence, connectedness, complexity). Accuracy (the proportion of all relapse classifications that were correct, whether positive or negative) will be reported for the predictive models.

Time frame
Monthly, up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.